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Personalis Receives Medicare Coverage for NeXT Personal® for Immunotherapy Monitoring Across Late-stage Solid Tumors
FREMONT, Calif., May 13, 2026--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for the company’s NeXT Personal minimal residual disease (MRD) test to include immunotherapy monitoring for patients with late-stage solid tumors.
About this update from Personalis, Inc.
Expanded coverage, supported by published data from the Vall d’Hebron Institute of Oncology (VHIO), enables Medicare beneficiaries receiving immunotherapy to access ultrasensitive MRD testing to monitor treatment response and predict clinical outcomes. FREMONT, Calif., May 13, 2026--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for the company’s NeXT Personal minimal residual disease (MRD) test to include immunotherapy monitoring for patients with late-stage solid tumors. This coverage determination is underpinned by landmark clinical evidence generated in collaboration with the Vall d’Hebron Institute of Oncology (VHIO). The recently published study demonstrated that NeXT Personal’s ultrasensitivity allows for ongoing evaluation of treatment response and the prediction of clinical outcomes in patients undergoing immunotherapy. By tracking tumor dynamics, the test can identify molecular responders and non-responders ahead of traditional radiologic imaging. Immunotherapy has revolutionized cancer care, with several hundred thousand patients in the US receiving immunotherapy per year, yet treatment response remains variable. Identifying which patients are responding and which are not is critical for optimizing therapeutic pathways, minimizing unnecessary toxicity, and managing the high costs associated with these advanced therapies. "Securing Medicare coverage for immunotherapy monitoring across solid tumors is a win for the patients we serve and the fight against cancer," said Chris Hall, Chief Executive Officer of Personalis. "This decision validates our strategy of moving NeXT Personal into the heart of active treatment management. For the first time, Medicare patients on immunotherapy will have an ultrasensitive MRD test to help their doctors see if a treatment is working in real-time." NeXT Personal leverages whole-genome sequencing and advanced noise-suppression technology to achieve sensitivity down to 1 part per million (PPM). By tracking up to ~1,800 patient-specific mutations, the assay provides a high-resolution view of a patient’s unique tumor profile. In the immunotherapy setting, where inflammatory responses can often compli...